Application 076033

Type: ANDA
Sponsor: ATLAS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076033-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24
A076033-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24
A076033-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076033-001	AB
A076033-002	AB
A076033-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076033-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076033-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076033-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076033-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076033-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076033-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076033-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076033-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076033-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076033-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076033-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076033-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076033-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076033-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076033-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076033-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076033-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076033-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076033-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076033-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076033-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076033-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076033-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076033-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076033-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076033-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076033-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076033-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076033-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076033-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076033-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076033-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076033-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076033-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076033-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076033-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076033-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076033-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076033-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076033-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076033-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076033-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076033-001	AB	1	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	76879512-3ab4-4acf-92e6-bba0fb75dd0e	2023-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a59327bd-a3ba-417b-9e91-4cd3a941e640	2023-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a79d2674-071f-4641-9b11-406e02c5530a	2023-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	93b0878d-b039-4479-8315-6dabf7e70611	2023-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Macleods Pharmaceuticals Limited	623b3bc6-1b07-4a04-bc7a-7fc695adf063	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d0bee456-c8cd-46a1-acb3-5313a8cddd30	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	474e2900-43bf-4ebe-9d29-4a7adb8a9429	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	6b8824c0-ece0-4b15-ba71-e893d6d2bfdf	2022-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Solco Healthcare US, LLC.	1016cad7-2198-483c-893b-e25fd397a226	2022-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d51f3618-4166-4925-8994-968a653ebc46	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d80aa4af-a8ce-4cae-b71c-05e1de829551	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	5f243894-bda3-4fa9-97e4-209dcb389dee	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS	ScieGen Pharmaceuticals, Inc.	16dc4008-7b5e-4c6d-9bc8-8db96be911a1	2022-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	738402d6-3700-46b2-a90c-2e8f2c354a39	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c789254c-be70-4d25-8c6c-b284b01eb513	2022-02-22	Boxed warning, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5e5fb10b-b874-43c9-9424-9080b9e866c8	2022-02-22	Boxed warning, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0b843f12-a654-4751-be1f-55e6fce163c9	2021-12-08	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1e298db3-439e-4e91-8f9e-01c3cdc4d552	2021-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3691	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3691	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3692	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3692	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3692	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3693	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3693	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3693	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
51991-805	metformin hydrochloride	metformin hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-806	metformin hydrochloride	metformin hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-807	metformin hydrochloride	metformin hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
71610-221	metformin hydrochloride	metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current